Array sonography for detection of esophageal events

ABSTRACT

The present invention relates to devices for detecting esophageal state changes. More specifically, the present invention relates to a lightweight, portable, user-operable device capable of detecting gastroesophageal reflux events. The sonography array can also be used to track the frequency of gastroesophageal reflux events, and can either store or deliver the data either to a practitioner&#39;s server or to a user&#39;s electronic device.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.15/689,874, titled ARRAY SONOGRAPHY FOR ESOPHAGEAL CHARACTERIZATION,which was filed on Aug. 29, 2017 (“the '874 application”) which claimspriority to U.S. Provisional Patent Application No. 62/382,738, titledARRAY SONOGRAPHY FOR REFLUX DETECTION CUSTOM ORTHOSES (“the '738Provisional application”). The entire disclosures of the '874application and the '738 Provisional application are hereby incorporatedherein

BACKGROUND State of the Art

The present invention relates to devices for characterizing the state ofthe esophagus which allows for detecting Gastroesophageal reflux,swallow events, etc. More specifically, the present invention relates toa lightweight, portable, user-operable device capable of detectingGastroesophageal reflux (GER) events. The sonography array can also beused to track the frequency of Gastroesophageal reflux events, and caneither store or deliver the data either to a practitioner's server or toa user's electronic device.

Field of Art

Gastroesophageal reflux is a common medical problem across the world.Heartburn, also called acid indigestion or acid reflux, is the mostcommon symptom of GER events. Occasional acid reflux may cause nausea,coughing, or a sharp pain in the chest, symptoms which are sometimesmistaken for more serious problems such as a heart attack or anembolism. Chronic acid reflux, however, can damage the mucosal lining ofthe esophagus, eventually resulting in injuries such as esophagealstrictures, Barrett's esophagus metaplasia, granulomas in the lungs(when there is a retrograde flow of gastric contents to the upperaero-digestive tract,) and even cancers. This damage can accumulatesilently, or with only mild symptoms, over the course of years.

Thus, determining whether a patient is truly experiencinggastroesophageal reflux, and how often, is of great importance inpreventative care. Because gastroesophageal reflux is rarely a constantcondition—that is, acid may enter the esophagus under particularconditions or at particular times, but not others—an in-office swab isnot effective to diagnose the problem. Various means of continuousmonitoring over several days are used, such as esophageal pH monitoring,in which a probe with radio transmitter is inserted nasally and worn forseveral days. The end of the catheter may be taped at the nostrils tohold the probe at the correct depth. The probe may be coated withviscous lidocaine to reduce severe chest pain, which occurs in around 5%of patients. Occasionally, the probe may dislodge prematurely from thepreferred placement and enter the stomach. Additionally, children andsome adults often cannot tolerate the irritation of wearing the probeand catheter.

Another technique is Multiple Intraluminal Impedance (MII). One of thehallmarks of gastroesophageal reflux is that small amounts of air orfluid escape the stomach and irritate the esophagus. This bolus of airor fluid has a different electrical impedance, compared with thesurrounding esophageal tissue or a bite of swallowed food. Refluxate, orstomach liquid, has a lower impedance than esophageal lining, while airhas higher impedance. In order to detect this bolus, however, clinicianshave needed to insert a catheter and probe—often steel rings separatedby an isolator—which suffers from the same drawbacks as the pH probeoutlined above, and there is no improvement of patent comfort whilewearing the device.

The bolus of air or stomach contents indicative of gastroesophagealreflux, however, can be detected non-invasively—for example, bytransabdominal ultrasound, which is performed at around 5 MHz. A bolusof air or liquid reflects these waves differently than surroundingesophageal tissue, and thus can be tracked. These monitoring devices arecomfortable to use, but are subject to many drawbacks. The equipment fora transabdominal ultrasound is bulky, expensive, and cannot be takenwith the patient or worn during daily activities. An experiencedpractitioner is required in order to correctly position the ultrasoundwand and interpret the image. As a result, typically monitoring is donefor only about 15 minutes.

Currently there is no device available for the detection ofgastroesophageal reflux that can be worn by as an ambulatory device overthe course of several days, is comfortable to wear, is simple enoughthat a caregiver may set up the device and instruct a patient during aroutine office visit, and does not interfere with the performance ofdaily activities. Thus there is a need for a device which not onlyperforms one or more of these functions for a variety of body sizes andages of people, but is also capable of taking frequent samples,distinguishing false positives from actual reflux events, and sending orstoring the data generated.

It is further advantageous if the device is capable of correlatingacoustic events (such as speech, coughs, burps, hiccups, etc.) with thedata of reflux events. Additionally, it is advantageous if the devicecontinues to function when dropped or tugged on, withstands aphysiological range of temperature and humidity, contains sufficientbattery power to operate continuously for a period of time greater than24 hours, and has a means to provide feedback to the user and offlineanalysis by a clinician.

SUMMARY OF THE INVENTION

The following summary of the present invention is not intended todescribe each illustrated embodiment or every possible implementation ofthe invention, but rather to give illustrative examples of applicationof principles of the invention.

In some embodiments, the sonography array for esophagealcharacterization includes an ambulatory data collection box with outputindicators, the output indicators including sensor status indicators andutility indicators; electrical leads which may be detachably attached tothe data collection box (or the data collection box may be wirelesslyconnected), and a sensor pad attached to the leads. In otherconfigurations, the data collection box and the sensors may bewirelessly connected. In some embodiments, the sensors may include anarray of at least two sensors, such as a grid or a strip of sensors.

In other embodiments, the sonography array for esophagealcharacterization also includes a speaker or other means of producingsound. In addition, the sonography array may include a microphone fordetecting audible sounds.

In still other embodiments, the sensors of the sonography array foresophageal characterization may be piezoelectric transducers, which mayemit sound waves in a range between 100 kHz and 10 MHz.

In some embodiments, the sensors of the sonography array for esophagealcharacterization may have a variable sampling frequency of 0.1 Hz to 100Hz.

In still other embodiments, the data collection box may be adapted toalter the sampling frequency of all of the sensors simultaneously.

In still other embodiments, the data collection box may be adapted todetermine which sensors produce a poor noise to signal ratio, and mayadjust the sampling frequency of just a few sensors rather than theentire grid, array, or strip of sensors.

In still other embodiments, the data collection box may also include abattery, a power and ground sensor, a voltage regulator, and a digitalprocessor or microprocessor.

In some embodiments, the battery of the data collection box may beadapted to power the sensors to enable them to perform normal recordingfunctions for greater than 24 hours.

In other embodiments, a software interface may be included, capable ofpresenting data from the sensors to a user at varying levels ofgranularity. In some embodiments, this granularity may be determined bya real time flag placed on the data, or by distance—e.g. the distancethat a reflux event travels up the esophagus.

In still other embodiments, one method of detecting esophageal state mayinclude: providing a data collection box, providing a sensor arraycomprising one or more sensors, connecting the sensor array to the datacollection box; calibrating the sensor array, selectively identifyingthe sensors positioned to detect esophageal state; and recording datagenerated by the sensors positioned to characterize the esophagealstate.

In some embodiments, one method of detecting gastroesophageal reflux mayinclude: providing an ancillary sensor, detecting esophageal eventswhich are not gastroesophageal reflux, and modulating the behavior ofthe sensors during esophageal events which are not gastroesophagealreflux.

In some methods of use, the data collection box may include sensorindicators, utility indicators, analog to digital converters, digital toanalog converters, driving circuitry, switching circuitry, signalamplification, filtering and processing circuitry, a digital signalprocessor, charging circuitry, an external direct current connector, aUSB connector, a real time clock, and voltage regulators.

In some embodiments, one method of detecting gastroesophageal reflux mayinclude flagging data generated by the sensors positioned to detectgastroesophageal reflux with a real time stamp or metadata, andproviding a graph of data generated by the sensors positioned to detectgastroesophageal reflux with a real time stamp.

These and other aspects of the present invention are realized in asonography array for esophageal characterization as shown and describedin the following figures and related description. It will be appreciatedthat various embodiments of the invention may not include each aspectset forth above and aspects discussed above shall not be read into theclaims unless specifically described therein.

BRIEF DESCRIPTION OF THE DRAWINGS

Various configurations of the present disclosure are shown and describedin reference to the numbered drawings, wherein:

FIG. 1 shows a top view of one embodiment of a data collection box;

FIG. 2 shows a side view of the data collection box of FIG. 1;

FIG. 3 shows a perspective view of one embodiment of a data collectionbox;

FIG. 4 shows an end view one embodiment of a data collection box;

FIG. 5 shows a process flow chart for software running on a datacollection box;

FIG. 6 shows an exemplary bolus in an esophagus with exemplary dataoutputs received by sensors;

FIG. 7 shows an exemplary process flow chart for a microprocessor torecord and store data relating to the acoustic signals detected at eachindividual transducer;

FIG. 8 shows an exemplary process flow chart for processing of theacoustic signals detected at each individual transducer;

FIG. 9 shows one embodiment of a hardware block diagram for a datacollection box;

FIG. 10 shows another embodiment of a hardware block diagram for a datacollection box; and

FIG. 11 shows an embodiment of a data collection box connecting tosensing apparatus.

It will be appreciated that the drawings are illustrative and notlimiting of the scope of the invention which is defined by the appendedclaims. The embodiments shown accomplish various aspects and objects ofthe invention, however it will be appreciated that the claims are to beinterpreted based on the language therein and not the various aspectsand objects which may or may not be achieved. It will be appreciatedthat it is not possible to clearly show each element and aspect of thepresent disclosure in a single figure, and as such, multiple figures arepresented to separately illustrate the various details of differentaspects of the invention in greater clarity. Similarly, not allconfigurations or embodiments described herein or covered by theappended claims will include all of the aspects of the presentdisclosure as discussed above. Additionally, not every embodiment needaccomplish all advantages of the present invention.

DETAILED DESCRIPTION

Various aspects of the invention and accompanying drawings will now bediscussed in reference to the numerals provided herein so as to enableone skilled in the art to practice the present invention. The skilledartisan will understand, however, that the methods described below canbe practiced without employing these specific details, or that they canbe used for purposes other than those described herein. Indeed, they canbe modified and can be used in conjunction with products and techniquesknown to those of skill in the art in light of the present disclosure.The drawings and the descriptions thereof are intended to be exemplaryof various aspects of the invention and are not intended to narrow thescope of the appended claims. Furthermore, it will be appreciated thatthe drawings may show aspects of the invention in isolation and theelements in one figure may be used in conjunction with elements shown inother figures.

Reference in the specification to “one configuration,” “one embodiment”“one aspect” or “a configuration,” “an embodiment” or “an aspect” meansthat a particular feature, structure, or characteristic described inconnection with the configuration may be included in at least oneconfiguration and not that any particular configuration is required tohave a particular feature, structure or characteristic described herein.

The appearances of the phrase “in one configuration” or similar phrasesin various places in the specification are not necessarily all referringto the same configuration, and may not necessarily limit the inclusionof a particular element of the invention to a single configuration,rather the element may be included in other or all configurationsdiscussed herein. Thus it will be appreciated that the claims are notintended to be limited by the representative configurations shownherein. Rather, the various representative configurations are simplyprovided to help one of ordinary skill in the art to practice theinventive concepts claimed herein.

Furthermore, the described features, structures, or characteristics ofembodiments of the present disclosure may be combined in any suitablemanner in one or more embodiments. In the following description,numerous specific details may be provided, such as examples of productsor manufacturing techniques that may be used, to provide a thoroughunderstanding of embodiments of the invention. One skilled in therelevant art will recognize, however, that embodiments discussed in thedisclosure may be practiced without one or more of the specific details,or with other methods, components, materials, and so forth. In otherinstances, well-known structures, materials, or operations may not beshown or described in detail to avoid obscuring aspects of theinvention.

Before the present invention is disclosed and described in detail, itshould be understood that the present invention is not limited to anyparticular structures, process steps, or materials discussed ordisclosed herein. More specifically, the invention is defined by theterms set forth in the claims. It should also be understood thatterminology contained herein is used for the purpose of describingparticular aspects of the invention only and is not intended to limitthe invention to the aspects or embodiments shown unless expresslyindicated as such. Likewise, the discussion of any particular aspect ofthe invention is not to be understood as a requirement that such aspectis required to be present apart from an express inclusion of that aspectin the claims.

It should also be noted that, as used in this specification and theappended claims, singular forms such as “a,” “an,” and “the” may includethe plural unless the context clearly dictates otherwise. Thus, forexample, reference to “a bracket” may include an embodiment having oneor more of such brackets, and reference to “the transducer” may includereference to one or more of such transducers.

As used herein, the term “substantially” refers to the complete ornearly complete extent or degree of an action, characteristic, property,state, structure, item, or result to function as indicated. For example,an object that is “substantially” enclosed would mean that the object iseither completely enclosed or nearly completely enclosed. The exactallowable degree of deviation from absolute completeness may in somecases depend on the specific context, such that ‘a circuit substantiallyenclosed in a pad’ would be substantially surrounded, even if the padincluded a slit or channel formed along a portion thereof. The use of“substantially” is equally applicable when used in a negativeconnotation to refer to the complete or near complete lack of an action,characteristic, property, state, structure, item, or result.

As used herein, the term “about” is used to provide flexibility to anumerical range endpoint by providing that a given value may be “alittle above” or “a little below” the endpoint while still accomplishingthe function associated with the range.

As used herein, a plurality of items, structural elements, compositionalelements, and/or materials may be presented in a common list forconvenience. However, these lists should be construed as though eachmember of the list is individually identified as a separate and uniquemember.

Concentrations, amounts, proportions and other numerical data may beexpressed or presented herein in a range format. It is to be understoodthat such a range format is used merely for convenience and brevity andthus should be interpreted flexibly to include not only the numericalvalues explicitly recited as the limits of the range, but also toinclude all the individual numerical values or sub-ranges encompassedwithin that range as if each numerical value and sub-range is explicitlyrecited. As an illustration, a numerical range of “about 1 to about 5”should be interpreted to include not only the explicitly recited valuesof about 1 to about 5, but also include individual values and sub-rangeswithin the indicated range. Thus, included in this numerical range areindividual values such as 2, 3, and 4 and sub-ranges such as from 1-3,from 2-4, and from 3-5, etc., as well as 1, 2, 3, 4, and 5,individually. This same principle applies to ranges reciting only onenumerical value as a minimum or a maximum. Furthermore, such aninterpretation should apply regardless of the breadth of the range orthe characteristics being described.

The invention and accompanying drawings will now be discussed inreference to the numerals provided therein so as to enable one skilledin the art to practice the present invention. The drawings anddescriptions are intended to be exemplary of various aspects of theinvention and are not intended to narrow the scope of the appendedclaims. Furthermore, it will be appreciated that the drawings may showaspects of the invention in isolation and the elements in one figure maybe used in conjunction with elements shown in other figures.

Turning now to FIG. 1, there is shown a top view of one embodiment of anelectronic packaging box, indicated generally at 1. The shape of the boxmay be approximately rectangular, or may be circular, or may beincorporated into a belt or other wearable object. In the embodimentshown in the figure, the box 1 may measure, for example, approximately 3inches by 4.5 or 5 inches, with a thickness of less than approximately0.5 inches. The corners 2 of the box 1 may be substantially rounded, inorder to make the box more comfortable to grip or to wear. The box 1 mayfurther include a USB or connectivity port 4, a power button 6, and oneor more indicator lights 8.

It may be advantageous if the electronics housing 1 is adapted toprotect the contents from sustained high humidity and temperatures andfluid or particle ingress, because the box 1 may be worn close to a bodyfor several days and under varying physiological conditions. Indeed,because gastroesophageal reflux may occur only under stressfulconditions, such as during exertion at high temperatures, it may beadvantageous if the box or housing 1 is protected against moistureinfiltration. Means of sealing the electronic housing 1 may include, forexample, sealing locknuts, limited enclosure penetrations, ensuring thatthe USB port 4 or other penetrations are located at a lower point whenthe device is worn as intended, and encasing components in electricaltape, insulating potting compounds, and/or butyl self-adhesive rubbertape. Alternately or in addition, the enclosure may be insulated.

It is advantageous if the box 1 is formed of a durable andshock-resistant material, for example, plastic or silicone. It isadvantageous if the electronics housing 1 passes a 5-foot drop test. Itis also advantageous if the surface can be finished or colored.

In some embodiments, the power button 6 may be recessed such that it isaccessible by an adult's thumbnail or a pen or other pointed object, butcannot be accidentally bumped or accessed by a child.

It is advantageous if the box 1 is reusable, in order to reduce costsincurred by patients. In order to facilitate use, the box 1 may beequipped with a belt clip, hook and loop fastener, or other means ofsecuring a small electronic device to a user.

In some embodiments in which sensors are attached to the electronicshousing 1 on multiple leads (discussed below, see also FIG. 7,) the box1 may include more than one indicator lights 8, including an indicatorlight 8 for each sensor adapted to display information such as whether aparticular sensor has made good contact, whether the sensor ispositioned properly, the sensor's recording status, whether the sensoris detecting possible reflux, whether the sensor is powered, and thelike. These modes may be cycled through using a cycling button (notshown.) Additionally, the lights 8 may be arrayed in pairs. This isparticularly useful when some sensors should be placed against thechest, and some against the corresponding location on the user's back.The paired lights arrangement may thus be used to indicate whether agiven pair of sensors are placed and synchronized properly.

An additional indicator light 8 may be provided to display battery life.

As shown in FIG. 2, some embodiments of the electronic housing 1 can bequite thin—less than 0.25 inches. While some embodiments may be up toone inch thick, it is advantageous if the electronics housing is smallenough to be worn comfortably under clothing. The box 1 may be shaped byany means known to one of skill in the art, such as punch, shear, lasercutting, casting, molding or injection molding, etc.

As shown in FIG. 3, in some embodiments the box 1 may includepenetration coverings, gates, or seals 10, which may be pried open orslid aside to access the power button 6, the mode-cycling button (notshown), and/or calibration button (not shown). This feature may reducethe infiltration of water unto the electronics housing unit 1.

As shown in FIG. 4, some embodiments may include a USB or connectivityport 4 and accompanying software capable of permitting a firmwareupgrade to the gastroesophageal reflux detector and/or a download ofinformation, when the electronics housing is connected to a computer.Additionally, the USB port may be configured to transmit data regardingreflux events automatically when attached to a computer with matchingsoftware.

As shown in FIG. 4, the power button 6 may additionally function as acalibration button—for example, when the power button is pressedcontinuously for a period, such as a period between three and fifteenseconds. A clinician may accordingly calibrate the device manually whenplacing it on a patient, viewing the results from each sensor via theindicator lights 8, rather than needing to use an external softwareapplication to calibrate the detector.

One advantage of the present embodiment is that the electronics housingmay be easily attached and removed from a patient—via, for example, abelt clip. This prevents the device from interfering with other medicalprocedures, such as an MRI or x-ray.

Because only the external surface of the recording unit 1 typically maytouch a patient's body, it may easily be wiped down with an alcoholswab, and need not be provided in a sterile condition. Unlike in manyother devices for detection of esophageal reflux, no wires are incontact with the patient's body, reducing the risk of shock or damage tothe wiring.

In addition, the electronics housing 1 may be equipped with a speakerunit 12, configured to provide audible feedback to a practitioner oruser. For example, the speaker unit 12 may produce a tone when a sensorcomes loose, or when battery life or storage capacity is low. A user orclinician may wish to accordingly reattach the sensor, recalibrate thedevice, or take steps necessary to download the recorded data.

Further, the electronics housing 1 may be configured to automaticallyshut down after a period of time, such as one or three days, or when apre-programmed number or severity of reflux events is recorded.

Turning now to FIG. 5, there is shown a flowchart of software processesand events or interruptions. During ordinary operation, the picturedembodiment activates one or more transducers for a period ofmilliseconds. The resulting signal is then received and assigned atimestamp. The ratio of emitted to received signal strength can indicatewhether an unwanted event has taken place, such as the detachment of asensor.

Upon recording the sensor signal data, the process is then repeated.Interruptions to the process may occur if, for example, the battery orstorage capacity has become low, or if accelerometer/gyroscopic data(generated by embodiments in which an accelerometer or gyroscope ispresent) suggest that the recording device or electronics housing (FIGS.1-4) has been dropped or otherwise violently disturbed.

Turning now to FIG. 9, there is shown a hardware block diagram of oneembodiment of components contained within the electronics housing (FIG.1.) The present embodiment includes utility indicators 20, which may be,for example, a battery indicator, a power plugged in indicator, a datastorage indicator, and a device on indicator, or other indicatorsrelevant to the functioning and condition of the gastroesophageal refluxdetector.

Sensor indicators 25 are adapted to provide information regarding thefunctioning of any attached sensors via, for example: adapting lights todim or blink when a particular sensor is functioning correctly orincorrectly, or the sensor has been placed in a position suitable fordiscovering useful data. It is advantageous if both utility indicators20 and sensor indicators 25 are for example bright enough, or loudenough, to provide information that can be discerned easily in daylightor in moderately noisy conditions.

The pictured hardware diagram further includes a power and ground sensor30, for the detection of electrical shorts or power outages, whethercaused by shock, damage, disconnected sensor, or low battery.

The pictured embodiment further includes at least one sensor 40. Thesensor 40 may be a grid or panel of several sensors, or several suchgrids. Additionally, the gastroesophageal reflux detector may include anarray of multiple sensors. The sensors may be, for example, apiezoelectric transducer, operating in a range from 100 kHz to 10 MHz.The transducers may be laid out in for example a 10×10 grid, formingsquares, strips or diamonds, which may be about 5 inches on a side.

In use, the transducer arrays or sensors 40 are positioned against theskin of the chest and the back, and detect a high frequency sound wavein typically the 100 kHz to 10 MHz range. These low frequencytransducers or sensors 40 detect acoustic reflections allowing theesophageal state to be identified by an acoustic signature depending onwhether or not the esophagus is open or closed (see detailed discussionbelow). In some embodiments, electromagnetic waves may be used insteadof mechanical sound waves, in which case radio frequency transducers areused in place of the ultrasound transducers, typically in a frequencyrange between 300 MHz to 300 GHz band.

Sensors 40 may be adapted to provide frequent sampling compared tocurrent technology, for example, sampling up to 100 times a second. Thesensors may be selected so that their frequency of sampling may beuniversally throttled (when battery life or storage capacity is low, forexample), or may be selectively throttled. (Some of the individualsensors in a 5-inch by 5-inch grid, for example, may never be in aposition over the esophagus unless the grid is peeled off and replaced.These sensors may never produce useful data or a functional signal tonoise ratio, and so may be throttled to sample much less frequently inorder to conserve battery life and storage space.) Transducers orsensors 40 attached to the small, wearable data acquisition system, mayrecord acoustic signals from the transducers for a period of over 24hours depending on the needs of the particular patient. Those acousticsignals may then be downloaded and processed by software, such assoftware that performs pattern recognition on the acoustic signals todetect esophageal state changes at discrete points along the length ofthe esophagus.

The signals that may captured by the ultrasonic transducers or sensors40 can be thought of in terms of A-Mode Ultrasound Imaging. In this modeof imaging, at every tissue interface or boundary between two differentmaterials, an acoustic reflection occurs. This reflection or echo isdetected by the transducer 40. Boundaries that have a greater impedancemismatch result in a stronger reflection which equates to a strongercurrent and thus voltage spike in the data. Mapping these echoes againstthe time of flight (TOF) or the time it takes for the acoustic wave topropagate through the various tissues and return to the transducer as areflection or echo allows for the generation of an acoustic signalsnapshot or frame from that transducer, where the y-axis is theamplitude of the echo, and the x-axis is the TOF. The acoustic signalscaptured by transducers or sensors 40 are capable of differentiatingchanges in the diameter and thickness of the esophageal lumen with aresolution of 1 mm.

The acoustic frames are captured from all transducers 40 in the arrayallowing for the identification of the esophageal state along its lengthat several transverse planes. These acoustic frames may typically becaptured from about 0.1 Hz to about 100 Hz. Frames then undergo signalprocessing to identify periods of time when an acoustic signature occurswhich indicates a bolus-filled esophagus at that transverse plane. Thesignal processing looks at surrounding frames and focuses on the echoesthat fall within a specified TOF which correlates to the depth of theesophagus from the ultrasonic transducer or sensor 40. The signalprocessing algorithm identifies the tissue layers of the esophagusincluding the outer and inner walls of the esophageal lumen as well asthe distance between these walls. Two key identifiers that indicate theesophagus is expanded is when the strong outer wall echoes have anincrease in TOF between them, as well as a concurrent decrease in theTOF of the echoes of the outer and inner esophageal lumen walls. Thiscan be seen in FIG. 6.

The left side of FIG. 6 shows an esophageal lumen dissected at twotransverse planes, one where the esophagus is collapsed 101, and theother where a bolus exists 105, leading to esophageal expansion. Theupper right is a representative drawing of the acoustic frame that wouldcharacterize a collapsed esophagus 101, with strong echoes 110 depictingthe outer walls and smaller echoes 115 being the inner walls. The y-axisis the amplitude strength of the echo (units may vary, for example, andmay typically be in microvolts), while x-axis is the TOF (units mayvary, for example, and may typically be microseconds). The lower rightis a representative drawing of the acoustic frame that wouldcharacterize an expanded esophagus 105, and the time between strongouter wall reflections 110 have increased and time between outer wall110 and inner wall 115 reflections have decreased. The y-axis is echoamplitude and the x-axis is TOF.

FIG. 7 illustrates an exemplary flow chart for collecting acoustic dataassociated with each transducer 40 in the array. It will be appreciatedthat while the flow charts herein are shown have discrete steps in aparticular order, the order may be changed and/or steps may be combined,and substantially the same results may be achieved. Thus the order ofthe steps is shown by way of example and not of limitation. Turning toFIG. 7, the microprocessor may first send a signal to the transmitterdriving circuit (Tx) to output a sound wave pulse on the transducer(120). (It will be appreciated that a transducer may be used, or atransmitter and receiver.)

The transducer then detects any resultant echoes for a predeterminedtime frame (for example, approximately 200 μs) and records this acousticsignal (125). The acoustic signal may then be buffered, amplified, andfiltered by the analog front end or analog front-end controller (130).The acoustic signal may then be digitized, such as with ananalog-to-digital convert to form a digital sample or acoustic frame(135). The acoustic frame is a series of discrete coordinates (x, y)where x represents the time of flight (TOF)(such as in μS or nS), and yrepresents the amplitude in μVolts. Each frame may then be timestamped(140). This process then repeats, for example, at a rate of 0.1 Hz to100 Hz, on each transducer 40 in the array (145). The process may berepeated for any desired amount of time. For example, 120 hours mayproduce clinically meaningful data, but more or less time may berecorded as desired.

At the same time the acoustic frames are captured, such as using themethod described in FIG. 7, supporting events may also be recorded. Forexample, positional sensors 41 may be provided and may detect theposition of the data collection box. This data may be given a timestamp.Positional sensors 41 may be used to detect and record the time at whicha patient changes position, i.e. sits up, lays down, stands up, etc. Thepositional sensors may be used to detect and record the time when apatient is active or sedentary. Auxiliary sensors 45 may also be used tocapture data at discrete points in time. For example, a microphone maybe used as an auxiliary sensor to detect and record acoustic events suchas a cough, cry, hiccup, chewing, etc.

The frames or time periods that are indicative of a bolus filledesophagus may be recorded/timestamped. When the data is analyzedoffline, these periods of an expanded esophagus can be seen at thevarious transverse planes. Noting the level of the expansion from oneplane to the other can dictate directionality of bolus travel, that is,expanded esophagus at proximal end of the array moving distal wouldindicate a swallow event, while the reverse would be reflux. Examiningall acoustic frames that represent an expanded esophagus would aid aclinician in identifying abnormal reflux episodes, or greater thannormal amounts of reflux.

FIG. 8 shows an exemplary flow chart for processing acoustic frames.Changes to the acoustic signals from one instant to the next can bethought of as an acoustic signature that identifies the physiologicalstate of the esophagus as either expanded or collapsed. Utilizingmultiple single point transducers at various transverse planes andexamining the acoustic signature, the state of the esophagus can bemonitored to determine the direction of bolus flow, distinguishingbetween swallow and reflux events.

Turning now to FIG. 8, the acoustic frames (such as acoustic framescollected in the manner shown in FIG. 7) may be combined to create anacoustic data movie. Each acoustic frame in the acoustic data moviecontains Points of Interest (POI). For example, in FIG. 6 the strongpeaks 110 depicting the outer walls, and smaller echoes 115 depictingthe inner walls may each be labeled as a POI. Each POI may represent anecho that correlates to the different layers of the esophagus, such asthe outer and inner esophageal wall which have a greater amplitude thanother POIs. The processing software may first identify each POI (155).Next, the software may use the POIs to establish a baseline acousticsignature representative of a collapsed or resting esophagus (160). Forexample, the TOF between POI and their corresponding amplitude may beused to specify the baseline for analyzing the acoustic frames. A framewith POIs that are closer in time may be used to establish the baselineof the collapsed or resting esophagus.

Next, successive frames are analyzed from a single transverse plane(transducer level) to identify changes in POIs to identify the acousticsignature of an expanded esophagus (165). Two changes in POI that mayhelp identify an expanded esophagus are (1) an increase TOF between theouter walls of esophageal lumen, and (2) a decrease in the TOF betweenthe outer and inner walls of the esophageal lumen. These may occur as aresult of the volume of the bolus expanding the esophagus, and causingit to stretch, bringing the outer and inner walls closer together. Thesoftware may identify an expanded esophagus by any suitable manner. Forexample, the software may compare the TOF between the outer walls of theesophageal lumen for a particular frame with the TOF between the outerwalls of the esophageal lumen established in the baseline. Where the TOFis greater than the baseline, the software may identify this frame as apossible bolus/reflux event. The software may inquire as to whetherthere is a change in the POIs for each successive acoustic frame (170),and where there is a change, this acoustic frame may be tagged for apossible expanded esophagus event (175). This process of identifyingPOIs (155), establishing a baseline (160), comparing POI changes fromsuccessive frames to identify an expanded state of the esophagus (165),determining if there is a POI change from successive frames (170), andtagging acoustic frames that have a change in POI (175), may be repeatedfor each transducer 40 of the array (180).

After an expanded state of the esophagus has been identified (175), theprocessor may use timestamps of supporting events to discriminate andidentify a true reflux event or add correlative data points (185). Forexample, timestamped events recorded from an auxiliary sensor such as amicrophone 45 may identify events such as a cough, cry, hiccup, chewing,etc., which are not indicative of a true reflux. Sensor events may becorrelated with timestamps of acoustic frames for expanded esophagusevents (190). Frames may then be tagged for additional processing andanalysis (195). The processor may also extract other data relating toeach true reflux (200), such as the bolus volume, duration, direction,severity, frequency, and other data associated with similar time stamps(such as data collected from positional sensors 41 used to detect andrecord the time at which a patient changes position, i.e. sits up, laysdown, stands up, etc.). The bolus volume and duration may be extractedfrom the acoustic data movie, the direction and severity/height inesophagus that the reflux traveled may be extracted from the acousticdata moving at multiple transverse planes, the frequency of reflux andclearing may be extracted from the number of occurrence over a period oftime in the acoustic movie.

Positional sensors 41 may be included to allow for additionalcorrelation of events preceding and during the reflux episode, i.e.laying down for extended periods, or increased activity includingwalking or running. These correlation events can be added to bolusdirectionality to aid in determining what might be causing the refluxand what next steps could be taken.

Turning now to FIG. 9, there is shown a block diagram of circuitry thatmay be used for the esophageal state detector. In addition to sensor(s)40, and positional sensors 41, an auxiliary or first pass sensor 45 maybe used in conjunction with the sensors 40. The auxiliary sensor 45 maybe, for example, a microphone. During periods in which a user is eatingor drinking, a high volume of sound may be produced. If this sound isdetected, the remaining portion of the sensors 40 may be safely andautomatically turned off, without danger of missing anotherwise-detectable reflux event (because the user is engaged inswallowing.) Conversely, many people experience high levels of refluxwhile sleeping, when esophageal sound levels are low. Sensors 40 may beconfigured to sample more frequently during this period. By including anauxiliary or first pass sensor 45, the detection device may operate moreefficiently, conserving battery life and reducing the number of samplesthat can provide little useful data.

In addition, the pictured embodiment includes an external direct current(DC) connector 50, USB hardware 54, and an SD card reader 58 forexpanded data storage capacity. The hardware may additionally includecharging circuitry 62, a voltage regulator 66, and a battery pack withbattery charge indicator 70. It is advantageous if the battery pack andcharge indicator 70 are in a sealed enclosure, and are not readilyaccessible, in the event the gastroesophageal reflux detector is droppedor broken open.

The esophageal reflux detector may further include a digital signalprocessor (DSP) or microprocessor 80. A digital signal processor is aspecialized microprocessor adapted for processing real-time data, but itwill be appreciated that any microprocessor with clock speed andcapacity to sufficiently process incoming data from the sensors 40before storage may be used. A DSP may further distinguish betweensignals arriving from various sensors, and may be adapted to disregardthe signals produced by sensors which do not provide meaningful data, orto throttle the number of samples taken by such sensors, which may havebeen improperly placed. This selectivity between sensors may conserveboth battery life and storage space.

Filters 84 may also be provided. Filters may be, for example, eithersoftware or hardware, analog or digital filters. However, providingdigital filters 84 may result in better separation of signal from noiseor interference, or other signals, particularly when many sensors 40 areplaced in close proximity, as with the grid or panel arrangements ofsensors 40.

The reflux detector may further include weak signal amplifiers oramplifiers 88, in order to magnify the signals produced by the sensors40 for better processing. The signal amplifiers 88 may be dynamicallyadjusted (for example, by the DSP 80) to amplify the output ofparticular sensors 40 more or less, according to the comparative qualityof data they produce. This feedback mechanism reduces the impact ofpoorly-positioned sensors on any final readouts of potential refluxevents, while preserving the usefulness of those sensors if, forexample, the sensor panel 40 has become detached and then been replaced.

FIG. 10 shows a more detailed hardware block diagram for electricalcomponents that may be used with the device for detecting an esophagealstate.

The reflux detector may further include a microprocessor or digitalprocessor 90, such as a field-programmable gate array (FPGA). It will beappreciated that additional memory units such as FLASH or EEPROM may beincluded.

Routines included on the microprocessor or digital processor 90 may be,for example, designed to protect patient confidentiality (for example,routines which delete data from the SD card 58 or other storage deviceif the detector is disassembled or if access is requested byunauthorized users), and may include a real time clock for accurate datestamps of data—an advantage in determining what activities the user wasengaging in when the reflux event occurred.

In some situations, the microprocessor or digital processor 90 may besufficiently capable of post-processing data so that results at aparticular level of granularity may be forwarded to another device, suchas the user's cellular phone. In such cases, the gastroesophagealcharacterization device generally indicated at 100 may include awireless data transfer mechanism, such as Bluetooth® , WiFi hardware,etc.

Additionally, the gastroesophageal characterization device detectorgenerally indicated at 100 may include a software interface capable ofdownloading and analyzing the data generated by the sensors 40. It maybe advantageous if the software allows a clinician to view potentialreflux events on varying timescales—that is, to zoom in or out, andexamine data sets of varying granularity—and also to allow a clinicianto apply different filters in order to sort the data, either manually orautomatically.

It is advantageous if the software highlights reflux events as well ascorrelated airway events (such as burping, or swallowing, which may bedetermined e.g. by a microphone 45), and is capable of sorting anddisplaying the data from up to twelve sensors or sensor grids. It isfurther advantageous if the software allows for determination of theduration of the reflux event, as well as the physical distance any givenreflux event travels in the esophageal tract (as measured by theplacement of sensors over the esophageal tract, for example, when a gridmeasuring 5 inches by 5 inches is placed over the esophageal tract).

Turning now to FIG. 11, there is shown an embodiment of a datacollection box connecting to sensing apparatus. In the presentembodiment, the data collection box 1 is connected to four individualsensors 40, however it will be appreciated that the sensors 40 mayinstead be panels of sensors laid out in a grid, (i.e. a sonographyarray) or a strip or array of sensors.

The sensors may be disconnectable from either or both the leads 42 orthe data collection box 1. Sensors 40 may be contained inenvironmentally-sealed enclosures or substantially enclosed in a pad,capable of operating over a physiological range of temperature andhumidity, and may be compatible with skin contact. Some advantagesmaintaining an environmentally sealed enclosure for the sensors includereducing signal noise and improving patient comfort. Sensors 40 may beprovided sterile, for single use only, and may include an adhesivebacking with a peel force not exceeding 1 lb per linear inch.

Sensors 40 connect to the data collection box 1 by means of leads 42.While separate leads 42 are shown, it will be appreciated that leads 42may instead comprise a single wire bundle (as, for example when thesensors 40 are to be placed very close together, such as when a panel orgrid of sensors is used.) Leads may be flexible, thin, and insulated.

It may be advantageous if the entire gastroesophageal characterizationassembly, including wires, sensors, and data collection box, weighsunder two pounds. Patients wearing sensors or sensor panels 40 reportgreater comfort when the weight of sensors or sensor panels 40 does notexceed approximately 200 grams, or seven ounces.

Thus there is disclosed a system and method relating to esophagealcharacterization. It will be appreciated that modifications may be madewithin the ordinary skill in the art and the appended claims areintended to cover such modifications. For example, the device and methoddescribed herein may be used to determine the collapsed or expandedstate of not just an esophagus, but also other expanded or collapsedstates or volumetric changes of other organs or vessels.

It will be appreciated that various aspects of the present disclosuremay be used together. Thus, for example, a system for monitoring andcharacterizing an esophageal state may include: an ambulatory datacollection box having output indicators, the output indicatorscomprising sensor status indicators and utility indicators; leads inelectric communication with the data box; and a sensor pad in electriccommunication with the leads, the sensor pad comprising at least twosensors. The system may also include at least one of the utilityindicators comprising a speaker, the sensors comprising ultrasonictransducers, the ultrasonic transducers being adapted to function in arange between 100 kHz to 10 MHz, the sensors having a samplingfrequency, the ambulatory data collection box being adapted to alter thesampling frequency of the sensors simultaneously, the sensors having asampling frequency, the ambulatory data collection box being adapted toalter the sampling frequency of one sensor independently of othersensors, the data collection box further comprising a battery, a powerand ground sensor, a voltage regulator, and a digital processor, and/orthe system further comprising a software interface, the softwareinterface comprising granularity selection, and combinations thereof.

Likewise, a method of detecting and characterizing an esophageal statemay include: providing the system for detecting an esophageal stateaccording to claim 1; attaching the at least two sensors proximal to anesophagus of a patient; emitting at least one sound wave at each of theat least two sensors; detecting at least one echo resulting from the atleast one sound wave at each of the at least two sensors; and recordinga time of flight between the at least one sound wave and at least oneecho at each of the at least two sensors. The method may further includethe step of attaching the at least two sensors proximal to an esophagusof the patient including attaching a first of the at least two sensorsin a first transverse plane and a second of the at least two sensors ina second transverse plane, the step of emitting at least one sound waveat each of the at least two sensors including emitting a plurality ofsound waves at each of the at least two sensors; the step of detectingat least one echo resulting from the at least one sound wave at each ofthe at least two sensors comprises detecting a plurality of echoes ateach of the at least two sensors; and wherein the step of recording atime of flight between the at least one sound wave and at least one echoat each of the at least two sensors comprises recording the time offlight between each of the plurality of sounds waves and the pluralityof echoes at each of the at least two sensors, further comprising thestep of: generating an acoustic time frame for each of the at least twosensors representative of the plurality of echoes and time of flight,further comprising the step of identifying at least one point ofinterest in the acoustic time frame, further comprising the step ofanalyzing a plurality of points of interest on a plurality of acoustictime frames, further comprising the step of analyzing multiple acousticframes to determine acoustic frames representative of a collapsedesophagus and an expanded esophagus, and/or further comprising the stepof providing an ancillary sensor to record an esophageal event notrepresentative of gastroesophageal reflux, and assigning a time to theesophageal event which is not gastroesophageal reflux, and combinationsthereof.

The present disclosure also teaches a system for characterizingesophageal events, the system comprising: a wearable acquisition devicecomprising a microprocessor; and an array of at least two ultrasonictransducers in electrical connection to the wearable acquisition device.The system may further include the at least two ultrasonic transducersincluding a first transducer and a second transducer, and wherein thefirst transducer is configured to be placed proximal to a firsttransverse plane of an esophagus, and the second transducer isconfigured to be placed proximal to a second transverse plane of theesophagus. The system may further include the wearable acquisitiondevice further comprises one or more auxiliary sensors and/or one ormore auxiliary sensors including at least one of a microphone, anaccelerometer, a gyroscope, and a positional sensor.

What is claimed is:
 1. A system for monitoring and characterizing anesophageal state comprising: an ambulatory data collection box havingoutput indicators, the output indicators comprising sensor statusindicators and utility indicators; leads in electric communication withthe data box; and a sensor pad in electric communication with the leads,the sensor pad comprising at least two sensors.
 2. The system of claim1, at least one of the utility indicators comprising a speaker.
 3. Thesystem of claim 1, the sensors comprising ultrasonic transducers.
 4. Thesystem of claim 3, the ultrasonic transducers being adapted to functionin a range between 100 kHz to 10 MHz.
 5. The system of claim 1, thesensors having a sampling frequency, the ambulatory data collection boxbeing adapted to alter the sampling frequency of the sensorssimultaneously.
 6. The system of claim 1, the sensors having a samplingfrequency, the ambulatory data collection box being adapted to alter thesampling frequency of one sensor independently of other sensors.
 7. Thesystem of claim 1, wherein the data collection box further comprises abattery, a power and ground sensor, a voltage regulator, and a digitalprocessor.
 8. The system of claim 1, further comprising a softwareinterface, the software interface comprising granularity selection.
 9. Amethod of detecting and characterizing an esophageal state, the methodcomprising: providing the system for detecting an esophageal stateaccording to claim 1; attaching the at least two sensors proximal to anesophagus of a patient; emitting at least one sound wave at each of theat least two sensors; detecting at least one echo resulting from the atleast one sound wave at each of the at least two sensors; and recordinga time of flight between the at least one sound wave and at least oneecho at each of the at least two sensors.
 10. The method according toclaim 9, wherein the step of attaching the at least two sensors proximalto an esophagus of the patient comprises attaching a first of the atleast two sensors in a first transverse plane and a second of the atleast two sensors in a second transverse plane.
 11. The method of claim10, wherein the step of emitting at least one sound wave at each of theat least two sensors comprises emitting a plurality of sound waves ateach of the at least two sensors; wherein the step of detecting at leastone echo resulting from the at least one sound wave at each of the atleast two sensors comprises detecting a plurality of echoes at each ofthe at least two sensors; and wherein the step of recording a time offlight between the at least one sound wave and at least one echo at eachof the at least two sensors comprises recording the time of flightbetween each of the plurality of sounds waves and the plurality ofechoes at each of the at least two sensors.
 12. The method of claim 11,further comprising the step of: generating an acoustic time frame foreach of the at least two sensors representative of the plurality ofechoes and time of flight.
 13. The method of claim 12, furthercomprising the step of identifying at least one point of interest in theacoustic time frame.
 14. The method of claim 13, further comprising thestep of analyzing a plurality of points of interest on a plurality ofacoustic time frames.
 15. The method of claim 14, further comprising thestep of analyzing multiple acoustic frames to determine acoustic framesrepresentative of a collapsed esophagus and an expanded esophagus. 16.The method according to claim 9, further comprising the step ofproviding an ancillary sensor to record an esophageal event notrepresentative of gastroesophageal reflux, and assigning a time to theesophageal event which is not gastroesophageal reflux.
 17. A system forcharacterizing esophageal events, the system comprising: a wearableacquisition device comprising a microprocessor; and an array of at leasttwo ultrasonic transducers in electrical connection to the wearableacquisition device.
 18. The system according to claim 17, wherein the atleast two ultrasonic transducers comprise a first transducer and asecond transducer, and wherein the first transducer is configured to beplaced proximal to a first transverse plane of an esophagus, and thesecond transducer is configured to be placed proximal to a secondtransverse plane of the esophagus.
 19. The system according to claim 17,wherein the wearable acquisition device further comprises one or moreauxiliary sensors.
 20. The system according to claim 19, wherein the oneor more auxiliary sensors comprise at least one of a microphone, anaccelerometer, a gyroscope, and a positional sensor.